Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. Fatal and nonfatal intracranial hemorrhage have also been reported .
Tipranavir is used in combination with ritonavir (Norvir®) to treat an infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have received HIV treatment in the past.
Tipranavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease from occurring. Tipranavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of tipranavir in children younger than 2 years of age. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of tipranavir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tipranavir.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine exactly as directed by your doctor. Do not change your dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Tipranavir is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.
If you are using this medicine with ritonavir capsules or oral liquid, you may take it with or without food. However, you should take this medicine with food if you are using it with ritonavir tablets.
Swallow the capsule whole. Do not break, crush, or chew it.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the capsules in the refrigerator until you are ready to open the bottle. Once you have opened the medicine bottle, you may store it at room temperature, away from heat, light, or moisture. The medicine is good for up to 60 days after you open the bottle. Throw away any unused capsules after 60 days and get a new bottle of medicine. .
Store the oral liquid at room temperature. Do not refrigerate or freeze it. The liquid must be used within 60 days after you open the bottle.
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
You should not use any of the following medicines while you or your child are taking tipranavir. Using these medicines together with tipranavir may increase your chance of having serious medical problems:
This medicine may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
This medicine may cause intracranial hemorrhage (bleeding in the brain). Make sure your doctor knows if you or your child have a bleeding disorder, or any medical condition that increases your chance of bleeding. Call your doctor right away if you have any unusual or unexplained bleeding.
Stop using this medicine and check with your doctor right away if you or your child have pain in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have more than one of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; fever or chills; itching; joint or muscle pain; severe rash; red skin lesions; sunburn; throat tightness; or sores, ulcers, or white spots in the mouth or on the lips.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.